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Beschreibung

Towards a better understanding of how medicines are used in society

Drug Utilization Research (DUR) is a discipline which combines aspects of pharmacotherapy, epidemiology, and health services research into an interdisciplinary set of methods for analyzing and assessing the prescribing, dispensing and consumption of medicines. It combines both qualitative and quantitative approaches to facilitate the safe and effective use of pharmaceuticals. Drug Utilization Research: Methods and Applications provides a comprehensive introduction to this discipline, prepared by an international team of authors with broad experience in numerous fields. Now reorganized and updated to reflect the latest research and global challenges, it is an indispensable resource for understanding the use of pharmaceuticals.

Readers of the second edition of Drug Utilization Research will find:

  • New chapters on methods, including more hands-on guidance on how to plan and conduct different types of drug utilization
  • A section on specific applications in areas such as psychotropics, opioids, cancer drugs, antibacterials, and cardiovascular drugs
  • A new section with case studies illustrating applications of DUR in different continents
  • Detailed treatment of subjects including DUR and health policy, DUR in specific populations, and many more

Drug Utilization Research is ideal for epidemiologists, pharmacists, physicians, nurses and others interested in drug use and its outcomes.

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Veröffentlichungsjahr: 2024

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Drug Utilization Research

Methods and Applications

Second Edition

EDITORS

Monique Elseviers

University of Antwerp, Belgium

Björn Wettermark

Uppsala University, Sweden

Tanja Mueller

University of Strathclyde, Scotland

Ria Benkő

University of Szeged, Hungary

Marion Bennie

University of Strathclyde, Scotland

Katarina Gvozdanović

University of Zagreb, Croatia

Mikael Hoffmann

Linköping University, Sweden

Irina Iaru

“Iuliu Hatieganu” University of Medicine and Pharmacy Cluj-Napoca, Romania

Verica Ivanovska

World Health Organisation, Geneva, Switzerland

Seán MacBride-Stewart

Pharmacy Services, NHS Greater Glasgow & Clyde, United Kingdom

Elisabetta Poluzzi

University of Bologna, Italy

Lisa Pont

University of Technology Sydney, Australia

Hege Salvesen Blix

Norwegian Institute of Public Health, Norway

Gabriel Sanfélix-Gimeno

Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Spain

Gisbert Selke

AOK Research Institute (WIdO), Germany

Katja Taxis

University of Groningen, The Netherlands

Ana Tomas Petrović

University of Novi Sad, Serbia

Indre Trečiokiene

Vilnius University, Lithuania

Sabine Vogler

Austrian National Public Health Institute, Austria

 

This edition first published 2024

© 2024 John Wiley & Sons Ltd

Edition History

[1e, 2016; John Wiley & Sons Ltd]

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by law. Advice on how to obtain permission to reuse material from this title is available at http://www.wiley.com/go/permissions.

The right of Monique Elseviers, Björn Wettermark, Tanja Mueller, Ria Benkő, Marion Bennie, Katarina Gvozdanović, Mikael Hoffmann, Irina Iaru, Verica Ivanovska, Seán MacBride-Stewart, Elisabetta Poluzzi, Lisa Pont, Hege Salvesen Blix, Gabriel Sanfélix-Gimeno, Gisbert Selke, Katja Taxis, Ana Tomas Petrović, Indre Trečiokiene, and Sabine Vogler to be identified as the authors of the editorial material in this work has been asserted in accordance with law.

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Trademarks: Wiley and the Wiley logo are trademarks or registered trademarks of John Wiley & Sons, Inc. and/or its affiliates in the United States and other countries and may not be used without written permission. All other trademarks are the property of their respective owners. John Wiley & Sons, Inc. is not associated with any product or vendor mentioned in this book.

Limit of Liability/Disclaimer of Warranty

The contents of this work are intended to further general scientific research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting scientific method, diagnosis, or treatment by physicians for any particular patient. In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. While the publisher and authors have used their best efforts in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.

A catalogue record for this book is available from the Library of Congress

Hardback ISBN: 9781119911654; ePub ISBN: 9781119911678; ePDF ISBN: 9781119911661; oBook ISBN: 9781119911685

Cover image: © FotografiaBasica/Getty Images

Cover design: Wiley

Set in 8.5/12pt MeridienLTStd by Integra Software Services Pvt. Ltd., Pondicherry, India

List of contributors

Mamoon A. AldeyabDepartment of PharmacySchool of Applied SciencesUniversity of HuddersfieldHuddersfieldUnited Kingdom

Anna Birna AlmarsdottirWHO Collaborating Centre for Research and Training in the Patient Perspective on Medicines Use Department of Pharmacy Faculty of Health and Medical Sciences University of Copenhagen Denmark

Morten AndersenDepartment of Drug Design and Pharmacology University of Copenhagen Copenhagen Denmark

Tuan Anh NguyenNational Ageing Research Institute Swinburne University Melbourne Australia

Ippazio Cosimo AntonazzoCentre for Public Health Research (CESP) University of Milan – Bicocca Milan Italy

Bernard BegauldFaculty of Medicine University of Bordeaux France

Ria BenkőInstitute of Clinical Pharmacy Faculty of Pharmacy University of Szeged Hungary

and

Emergency Department Albert-Szent Györgyi Medical Centre Central Pharmacy University of Szeged Hungary

Kathleen BennettData Science Centre School of Population Health RCSI University of Medicine and Health Sciences Dublin Ireland

Marion BennieStrathclyde Institute of Pharmacy and Biomedical Sciences University of Strathclyde Glasgow Scotland, UK

Hege Salvesen BlixAntibiotic Resistance and Infection Prevention Norwegian Institute of Public Health OsloNorway

and

WHO Collaborating Centre for Drug Statistics Methodology Norwegian Institute of Public Health Oslo Norway

Jonathan BrettSt Vincent’s Clinical School UNSW Medicine UNSW Sydney Australia

and

School of Population Health Faculty of Medicine and Health University of New South Wales Sydney Australia

Shawn BugdenSchool of Pharmacy Memorial University Newfoundland Canada

Johanita BurgerMedicine Usage in South Africa (MUSA) North-West University South Africa

Tatiana Chama Borges LuzRene Rachou Research Center Oswaldo Cruz Foundation Brazil

and

eHealth Institute Department of Medicine and Optometry Linnaeus University Sweden

and

Department of Learning, Informatics, Management and Ethics (LIME) Karolinska Institutet Stockholm Sweden

Antonio ClavennaLaboratory of Child Health and Development Epidemiology Istituto di Ricerche Farmacologiche Mario Negri IRCCS Milan Italy

Samuel CoenenCentre for General Practice Department of Family Medicine and Population Health (FAMPOP) and Laboratory of Medical Microbiology Vaccine and Infectious Disease Institute (VAXINFECTIO) University of Antwerp – Campus Drie Eiken Antwerp Belgium

Luciane Cruz LopesUniversity of Sorocaba Sao Paulo Brazil

Petra DenigDepartment of Clinical Pharmacy and Pharmacology University Medical Center Groningen University of Groningen Groningen The Netherlands

Alexandra L. DimaHealth Technology Assessment in Primary Care and Mental Health (PRISMA) Institut de Recerca Sant Joan de Deu Barcelona Spain

Louise C. DruedahlCentre for Advanced Studies in Biomedical Innovation Law (CeBIL) Faculty of Law University of Copenhagen Denmark

Carlos E. DuránDepartment of Data Science and Biostatistics University Medical Center Utrecht The Netherlands

Monique ElseviersDepartment of Clinical Pharmacology University of Ghent Ghent Belgium

and

Centre for Research and Innovation in Care (CRIC) University of Antwerp Antwerp Belgium

Joseph FadareDepartment of Pharmacology and Therapeutics Ekiti State University College of Medicine Ado-Ekiti Nigeria

Claudia Garcia Serpa Osorio-de-CastroDepartment of Medicines Policies and Pharmaceutical Services Sergio Arouca National School of Public Health Oswaldo Cruz Foundation Rio de Janeiro Brazil

Kristina GaruolienePharmacy and Pharmacology Center Faculty of Medicine Vilnius University Lithuania

Cristina Mihaela GhiciucDepartment of Pharmacology, Clinical Pharmacology and Algesiology Faculty of Medicine Grigore T. Popa University of Medicine and Pharmacy of Iasi Romania

Catherine GoetzingerNational Health Observatory Luxembourg and Deep Digital Phenotyping Research Unit Department of Precision Health Luxembourg Institute of Health Strassen Luxembourg

and

Faculty of Science, Technology and Medicine University of Luxembourg Luxembourg

Katarina GvozdanovićPharmacoepidemiology Department Andrija Štampar Teaching Institute of Public Health ZagrebCroatia

Mohammadhossein HajiebrahimiDepartment of Pharmacy Faculty of Pharmacy Uppsala University Sweden

Aleksi HaminaNiuvanniemi Hospital Kuopio Finland

and

Norwegian Centre for Addiction Research (SERAF) Institute of Clinical Medicine University of Oslo Oslo Norway

Juan M. Hincapie-CastilloGillings School of Global Public Health University of North Carolina Chapel Hill, NC USA

Mikael HoffmannThe NEPI Foundation Stockholm Linköping Sweden

and

Unit of Health Care Analysis Department of Health, Medicine and Caring Sciences (HMV) Linköping University Linköping Sweden

and

Department of Pharmacy Faculty of Pharmacy Uppsala University Sweden

Dyfrig HughesCentre for Health Economics & Medicines Evaluation Bangor University United Kingdom

Irina IaruDepartment of Pharmacology, Physiology and Pathophysiology Faculty of Pharmacy Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca Romania

Verica IvanovskaWorld Health Organization Geneva

Sofia Kälvemark SporrongDepartment of Pharmacy Faculty of Pharmacy Uppsala University Sweden

and

Department of Pharmacy Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark

Anita KotwaniDepartment of Pharmacology Vallabhbhai Patel Chest Institute University of Delhi Delhi India

Janet KrskaClinical and Professional Pharmacy Medway School of Pharmacy United Kingdom

Amanj KurdiStrathclyde Institute of Pharmacy and Biomedical Sciences University of Strathclyde Glasgow Scotland, UK

and

Department of Pharmacology and Toxicology College of Pharmacy Hawler Medical University Erbil Kurdistan Region Government Iraq

and

Department of Clinical Pharmacy College of Pharmacy Al-Kitab University Kirkuk Iraq

and

School of Pharmacy Sefako Makgatho Health Sciences University Pretoria South Africa

Irene LangnerAOK Research Institute (WIdO) Berlin Germany

George LeckieCentre for Multilevel Modelling (CMM) School of Education University of Bristol United Kingdom

Carl LlorThe Foundation University Institute for Primary Health Care Research Jordi Gol i Gurina (IDIAPJGol), Via Roma Health Centre Barcelona Spain

Seán MacBride-StewartPharmacy Services NHS Greater Glasgow and Clyde Glasgow Scotland

Lorenzo G. MantovaniDepartment of Statistics School of Medicine University of Milan Italy

Maria MatuzInstitute of Clinical Pharmacy Faculty of Pharmacy University of Szeged Hungary

Giampiero MazzagliaCentre for Public Health Research (CESP) School of Medicine and Surgery University of Milan – Bicocca Milan Italy

Stuart McTaggartPublic Health Scotland Edinburgh United Kingdom

Juan MerloUnit for Social Epidemiology Department of Clinical Sciences Centre for Primary Health Care Research Faculty of Medicine Lund University Malmo Sweden

Peter MolMedicines Evaluation Board Utrecth The Netherlands

and

Department of Clinical Pharmacy and Pharmacology University Medical Centre Groningen University of Groningen The Netherlands

Aminath MoominaMedicines and Goods Therapeutic Division Food and Drug Authority Republic of Maldives

Tanja MuellerStrathclyde Institute of Pharmacy and Biomedical Sciences University of Strathclyde Glasgow Scotland

Urska Nabergoj-MakovecDepartment of Social Pharmacy Faculty of Pharmacy University of Ljubljana Ljubljana Slovenia

Marmar NekoroSwedish Knowledge Centre on Pharmaceuticals in the Environment Swedish Medical Products Agency P.O Box 26, SE-75103Uppsala Sweden

and

Affiliated to the Faculty of Pharmacy Uppsala University Sweden Biomedicinskt Centrum BMC Box 580, 751 23 Uppsala Sweden

Evalill NilssoneHealth Institute Department of Medicine and Optometry Linnaeus University Sweden

and

Department of Learning, Informatics, Management and Ethics (LIME) Karolinska Institutet Stockholm Sweden

Hedvig NordengPharmacoepidemiology and Drug Safety Research Group Department of Pharmacy Faculty of Mathematics and Natural Sciences University of Oslo Oslo Norway

Ingvild OdsbuDepartment of Chronic Diseases The Norwegian Institute of Public Health Oslo Norway

Elisabetta PoluzziPharmacology Unit Department of Medical and Surgical Sciences University of Bologna Bologna Italy

Lisa G. PontDiscipline of Pharmacy Graduate School of Health University of Technology Sydney Sydney Australia

Emanuel RaschiPharmacology Unit Department of Medical and Surgical Sciences University of Bologna Italy

Lotte RasmussenClinical Pharmacology, Pharmacy and Environmental Medicine Department of Public Health University of Southern Denmark Odense Denmark

Elizabeth RougheadQuality Use of Medicines and Pharmacy Research Centre University of South Australia Australia

Zainab Said Al-HashimyDirectorate of Pharmacy and Medical Stores Khawlah Hospital Muscat Oman

Per-Jostein SamuelsenRegional Pharmacovigilance and Medicines Information Centre (RELIS) University Hospital of North Norway Tromsø Norway

Gabriel Sanfelix-GimenoHealth Services Research and Pharmacoepidemiology Unit Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO) Valencia Spain

Yared Santa-Ana-TéllezUtrecht Centre for Pharmaceutical Policy & Regulation Utrecht Institute for Pharmaceutical Sciences (UIPS) Utrecht University Utrecht The Netherlands

Katharina Schmidt-MendeAcademic Primary Health Care Centre Stockholm Region Stockholm Sweden

and

Division of Family Medicine and Primary Care Department of Neurobiology Care Sciences and Societly Karolinska Institute Huddinge Sweden

Marie P. SchneiderSchool of Pharmaceutical Sciences University of Geneva Switzerland

Gisbert W. SelkeAOK Research Institute (WIdO) Berlin Germany

Janne SeppEstonian State Agency of Medicines University of Tartu Tartu Estonia

Maurizio SessaDepartment of Drug Design and Pharmacology University of Copenhagen Copenhagen Denmark

Saeed ShakibfarDepartment of Drug Design and Pharmacology University of Copenhagen Copenhagen Denmark

Ingrid SketrisCollege of Pharmacy Dalhousie, University Halifax Nova Scotia Canada

Svetlana SkurtveitNorwegian Centre for Addiction Research (SERAF) Institute of Clinical Medicine University of Oslo Oslo Norway

and

Department of Chronic Diseases Norwegian Institute of Public Health University of Oslo Oslo Norway

Douglas SteinkeDivision of Pharmacy and Optometry School of Health Sciences University of Manchester Manchester United Kingdom

Nithima SumpraditMedicines Regulation Division Food and Drug Administration Ministry of Public Health Thailand

Maha TalaatWHO Eastern Mediterranean Office World Health Organisation Eastern Mediterranean Region Cairo Egypt

Katja TaxisDepartment of PharmacoTherapy, Epidemiology & EconomicsFaculty of Science and Engineering University of Groningen Groningen The Netherlands

Wade ThompsonDepartment of Anesthesiology, Pharmacology, and Therapeutics Faculty of Medicine The University of British Columbia Vancouver Canada

Henrik Toft SørensenDepartment of Clinical Epidemiology Aarhus University Denmark

Ana Tomas PetrovićDepartment of Pharmacology and Toxicology Faculty of Medicine Novi Sad University of Novi Sad Novi Sad Serbia

Janine TraulsenDepartment of Social and Clinical Pharmacy University of Copenhagen Denmark

Indrė TrečiokienėPharmacy and Pharmacology Centre Faculty of Medicine Vilnius University Lithuania

and

Department of PharmacoTherapy, Epidemiology & Economics Faculty of Science and Engineering University of Groningen Groningen The Netherlands

Gianluca TrifiròDepartment of Diagnostics and Public Health University of Verona Italy

Ilse TruterDrug Utilisation Research Unit (DURU) Department of Pharmacy Faculty of Health Sciences Nelson Mandela University South Africa

Cara UsherNational Centre for Pharmaeconomics St James’s Hospital Dublin Ireland

Job F.M. van BovenDepartment of Clinical Pharmacy and Pharmacology Medication Adherence Expertise Centre of the Northern Netherlands (MAECON) University Medical Centre Groningen University of Groningen Groningen The Netherlands

Liset van DijkNivel (Netherlands institute for health services research) The Netherlands

and

University of Groningen The Netherlands

Marleen van GelderDepartment for Health Evidence Radboud Institute for Health Sciences Radboud University Medical Centre Nijmegen The Netherlands

Robert Vander SticheleUnit of Medical Informatics Department of Public Health Ghent University Ghent Belgium

Marcia VervloetUniversity of Groningen The Netherlands

Johanna VillénFaculty of Pharmacy Uppsala University Sweden Biomedicinskt Centrum BMC Box 580 751 23 Uppsala Sweden

Sabine VoglerWHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department Austrian National Public Health Institute Vienna Austria

Mia von EulerFaculty of Medicine and Health Örebro University Sweden

Bernard VrijensAARDEX Group & University of Liège Belgium

Björn WettermarkDepartment of Pharmacy Faculty of Pharmacy Uppsala University Sweden

and

Pharmacy and Pharmacology Centre Faculty of Medicine Vilnius University Lithuania

and

The NEPI Foundation Sweden

Ksenia ZagorodnikovaAlmazov National Medical Research Centre St Petersburg Russia

Jing ZhaoDepartment of Pharmacy University of Oslo Oslo Norway

Helga ZoegaCentre of Public Health Sciences Faculty of Medicine University of Iceland Iceland

Preface to the second edition

One decade ago, the European Drug Utilization Research Group (EuroDURG) took the initiative to prepare a book entitled Drug Utilization Research: Methods and Applications. Rather than limiting this work to a handbook focusing only on the methodological issues of Drug Utilization Research (DUR), it was our intention to also offer a complete overview of the different applications of DUR, ranging from DUR and health policy over DUR in specific areas and populations to DUR applications in the broader field of pharmacoepidemiology and strategies to improve the quality of prescribing.

Since the field of DUR has experienced a major expansion during the last decade, the necessity for an update of the first edition was emerging. Additionally, the need for a comprehensive educational handbook gained interest in a broader field of academic researchers, civil service workers, health insurances and health authorities, since more researchers have the opportunity to work with available DU data that wait to be analyzed to support policy decisions.

The preparation of this second edition of the DURbook started in 2020 with the distribution of a questionnaire offering more insight into who was using the book (83% were academic researchers), the reason for using the book (mainly as a reference work and for teaching material) and the need to publish the second edition in digital as well as printed format. Furthermore, we received the suggestion to add a new part focusing on the current state of drug utilization research at the global level. Using the contacts of the Special Interest Group of DUR (SIGDUR) of the International Society of Pharmacoepidemiology (ISPE), we were able to assemble testimonies of initiatives in DUR from across the world.

This new edition consists of four overarching sections: introduction, methods, applications and the new fourth section on the globalization of DUR. New chapters were added handling, e.g., aggregate level analyses of DU data, artificial intelligence/machine learning, ethical aspects in DUR, and environmental pharmacoepidemiology. In the previous edition, the application section was mostly a collection of published research. The updated content focusses on specific challenges, and expands on how to deal with these, keeping in mind the educational purpose of the book. In contrast with the previous edition, we have been able to add 30 key references to each chapter, hosting this time only the additional references online.

The making of this second edition followed a strict organizational pattern. The editorial board (EB) met virtually on a monthly basis. Two EB members were assigned to each section of the book. They were responsible for the communication with the authors of their chapters, discussing the content, keeping deadlines, and having a first critical reading of the delivered chapters. A further internal review of each chapter was mainly completed during hybrid DURbook weekends organized at the universities of Vilnius, Copenhagen, Uppsala, Bologna and Antwerp (see acknowledgement). After revision, based on the comments of section leaders and internal reviewers, an updated version of each chapter was sent for further comments to one or two external reviewers not involved in the development of the book (see list of external reviewers).

Drug utilization research is passing through a remarkable period of conceptual development. Although we attempted to incorporate the most up-to-date knowledge in this field, we are aware about possible gaps in our descriptions, about incompleteness and imperfections. Nevertheless, we hope that this second edition of the DURbook will become a helpful tool and a source of inspiration for all researchers working with drug utilization data.

Acknowledgements

The editors want to express their gratitude to the 98 contributing authors for their willingness to share their specific expertise in drug utilization research. They particularly appreciate their open-minded attitude discussing the content of their chapters, their attempts to respect all deadlines and their efforts to handle concisely all review comments.

This second edition of the DURbook is built on the experience and content of the previous one. We remain grateful to all editors and authors that were no longer involved in the creation of this second edition but contributed substantially to the first edition.

We appreciate the utmost importance of the involvement of our 62 external reviewers. With their independent evaluations and constructive comments, they contributed considerably to improve the quality of each chapter (see list of external reviewers). Special thanks go to Tanja Mueller for her administrative help and persistent efforts to find and contact the most suitable specialists in the field for performing these external reviews.

The editors are indebted to the members of the advisory board for their valuable suggestions in creating this second edition:

Johanita Burger, Medicine Usage in South Africa, North-West University, South Africa

Frank May, Faculty of Health and Behavioral Sciences, University of Queensland, Australia

Claudia Osorio-De-Castro, School of Public Health, Oswaldo Cruz Foundation, Brazil

Veronika Wirtz, Center for Global Health and Development, Boston University, United States

For the organization of editorial board (EB) meetings, the editors are grateful for the organizational and financial support of:

Vilnius University, Lithuania (May 2022)

University of Copenhagen, Denmark (August 2022)

Uppsala University, Sweden, and the Swedish Network of Pharmacology-epidemiology (NEPI) (October 2022)

Bologna University, Italy (November 2022)

External Reviewers

Katri Aaltonen

INVEST Research Flagship Centre

University of Turku

Finland

Silvia Alessi-Severini

Rady Faculty of Health Sciences

College of Pharmacy

University of Manitoba

Canada

Anthony J. Avery

Centre for Academic Primary Care

School of Medicine

University of Nottingham

United Kingdom

Francesco Barone Adesi

Center for Research and Training in Disaster Medicine, Humanitarian Aid, and Global Health

Department of Translational Medicine

Università del Piemonte Orientale

Novara

Italy

Ylva Boettiger

Department of Biomedical and Clinical Sciences

Division of Clinical chemistry and pharmacology

Linköping University

Sweden

Stephen Campbell

Division of Population Health, HSR & Primary Care

School of Health Sciences

Faculty of Biology, Medicine and Health

University of Manchester

United Kingdom

Gillian Caughey

University of South Australia

Australia

Antonio Clavenna

Laboratory of Child Health Development Epidemiology

Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Milan

Italy

Luciane Cruz Lopes

University of Sorocaba

Sao Paulo

Brazil

Tinne Dilles

Centre for Research and Innovation in Care

University of Antwerp

Belgium

Katherine Donegan

Medicines and Healthcare products Regulatory Agency

London

United Kingdom

Jaime Espin

Andalusian School of Public Health

Granada

Spain

Albert Figueras

Department of Pharmacology, Therapeutics and Toxicology

Universitat Autonoma de Barcelona

Spain

Claudia Geue

Health Economics and Health Technology Assessment

Institute of Health and Wellbeing

University of Glasgow

United Kingdom

Brian Godman

Strathclyde Institute of Pharmacy and Biomedical Sciences

University of Strathclyde

Glasgow

Scotland

Jolanta Gulbinovic

Department of Pathology, Forensic Medicine and Pharmacology

Faculty of Medicine

Vilnius University

Lithuania

Lars Gustafsson

Division of Clinical Pharmacology

Department of Laboratory Medicine

Karolinska Institutet

Stockholm

Sweden

Eelko Hak

Faculty of Science and Engineering, PharmacoTherapy, -Epidemiology and -Economics

Groningen Research Institute of Pharmacy

University of Groningen

Netherlands

Ursula Kirchmayer

Department of Epidemiology

Lazio Regional Health Service

Rome

Italy

Reidun Kjome

Department of Global Public Health and Primary Care

University of Bergen

Norway

Francesca Kolitsopoulos

Global Medical Epidemiology

Pfizer

New York

USA

Amanj Kurdi

Strathclyde Institute of Pharmacy and Biomedical Sciences

University of Strathclyde

Glasgow

Scotland

Jennifer Laskey

NHS Greater Glasgow and Clyde

West of Scotland Cancer Network

Glasgow

United Kingdom

Deborah Layton

IQVIA

London

United Kingdom

Anne Lee

NHS Scotland/Scottish Medicines Consortium

United Kingdom

David Lee

Pharmaceuticals and Health Technologies Group

Management Sciences for Health

Arlington

VA, USA

Hubert Leufkens

Utrecht Centre for Pharmaceutical Policy and Regulation

University of Utrecht

Netherlands

Marie Linder

Centre for Pharmacoepidemiology

Clinical Epidemiology Division

Department of Medicine Solna

Karolinska Institutet

Stockholm

Sweden

Carl Llor

Department of Public Health

Research Unit of General Practice

University of Southern Denmark

Odense

Denmark

Carlotta Lunghi

Department of Medical and Surgical Sciences

University of Bologna

Italy

Aukje Mantel-Teeuwisse

School of Pharmacy

University of Utrecht

Netherlands

Zeljana Margan Koletic

Department for Pharmacovigilance and Rational Pharmacotherapy

Croatian Agency for Medicinal Products and Medical Devices

Zagreb

Croatia

Maria Matuz

Institute of Clinical Pharmacy

Faculty of Pharmacy

University of Szeged

Hungary

Frank May

Drug and Therapeutics Information Service

Repatriation General Hospital

Daw Park

South Australia

Australia

Enrica Menditto

Center of Pharmacoeconomics and Drug Utilization Research

University of Naples

Federico II

Italy

Nikica Mirosevic Skvrce

Department for Pharmacovigilance and Rational Pharmacotherapy

Croatian Agency for Medicinal Products and Medical Devices

Zagreb

Croatia

Antje Neubert

Zentrale fuer klinische Studien in der Paediatrie

Uniklinikum Erlangen

Germany

Ulrika Nörby

Region Stockholm

Health and Medical Care Administration

Sweden

Claudia Garcia Serpa Osorio de Castro

Department of Medicines Policies and Pharmaceutical Services

Sergio Arouca National School of Public Health

Oswaldo Cruz Foundation

Rio de Janeiro

Brazil

Carlo Piccinni

Fondazione ReS (Ricerca e Salute)

Rome

Italy

Graham Prestwich

PRIMM

Prescribing and Research in Medicines Management (UK & Ireland)

United Kingdom

Lotte Rasmussen

Clinical Pharmacology, Pharmacy and Environmental Medicine

Department of Public Health

University of Southern Denmark

Odense

Denmark

Mette Reilev

Clinical Pharmacology

Pharmacy and Environmental Medicine

University of Southern Denmark

Odense

Denmark

Johan Reutfors

Centre for Pharmacoepidemiology

Clinical Epidemiology Division

Department of Medicine Solna

Karolinska Institutet

Stockholm

Sweden

Renata Cristina Rezende Macedo do Nascimento

School of Pharmacy

Federal University of Ouro,

Preto

Brazil

Monica Sabate

Hospital Universitari Vall d’Hebron Servei de Farmacologia Clínica

Vall d’Hebron Institut de Recerca (VHIR)

Barcelona

Spain

Maribel Salas

Epidemiology and Cardiovascular Therapeutic Area

Daiichi Sankyo Inc.

Parsippany

New Jersey

USA

Ingrid Schubert

PMV Forschungsgruppe an der Medizinischen Fakultät und Universitätsklinikum Köln (AÖR)

Universität zu Köln

Germany

Reinhard Schuster

Gesundheitsökonomie/Biometrie/Medizinische Informatik

Medizinischer Dienst Nord

Lübeck

Germany

Gyöngyver Soos

Institute of Clinical Pharmacy

University of Szeged

Hungary

Cecilia Stålsby Lundborg

Health Systems and Policy (HSP): Medicines, Focusing Antibiotics

Department of Global Public Health

Karolinska Institutet

Stockholm

Sweden

Douglas Steinke

Division of Pharmacy and Optometry

School of Health Sciences

University of Manchester

Manchester

United Kingdom

Henrik Støvring

Department of Public Health

Aarhus University

Denmark

Mina Tadrous

Leslie Dean Faculty of Pharmacy

University of Toronto

Canada

Petra Thuerman

Department Humanmedizin - Fakultät für Gesundheit

Universität Witten/Herdecke

Witten

Germany

Ilse Truter

Drug Utilization Research Unit (DURU)

Department of Pharmacy

Faculty of Health Sciences

Nelson Mandela University

South Africa

Eric van Ganse

RESHAPE - Research on Healthcare Performance

Lyon

France

Marie Viprey

RESHAPE - Research on Healthcare Performance

Lyon

France

Vera Vlahović-Palčevski

Medical Faculty

University of Rijeka

Croatia

Helle Wallach Kildemoes

Statistics Denmark

University of Copenhagen

Denmark

Natalie Weir

Strathclyde Institute of Pharmacy and Biomedical Sciences

University of Strathclyde

Glasgow

United Kingdom

Che Suraya Zin

Big Data Research Group

Kulliyyah of Pharmacy

International Islamic University Malaysia

Kuantan

Pahang

Malaysia

About the Companion Website

This book is accompanied by a companion website:

www.wiley.com/go/elseviers/drug_utilization_research2e

The website includes:

Full References List

PART 1

Introduction to drug utilization research

CHAPTER 1Introduction to drug utilization research

Björn Wettermark1, 2, 3, Monique Elseviers4, 5, Tanja Mueller6, Anna Birna Almarsdottir7, Ria Benkő8, 9, Marion Bennie6, Irina Iaru10, Katarina Gvozdanovic11, Mikael Hoffmann3, Verica Ivanovska12, Seán MacBride-Stewart13, Elisabetta Poluzzi14, Lisa G. Pont15, Hege Salvesen Blix16, 17, Gabriel Sanfelix-Gimeno18, Gisbert W. Selke19, Katja Taxis20, Ana Tomas Petrović21, Indrė Trečiokienė2, 20 and Sabine Vogler22

1Department of Pharmacy, Faculty of Pharmacy Uppsala University Sweden 2Pharmacy and Pharmacology Centre, Faculty of Medicine Vilnius University Lithuania 3The NEPI foundation Stockholm, Sweden 4Department of Clinical Pharmacology University of Ghent Ghent Belgium 5Centre for Research and Innovation in Care (CRIC), University of Antwerp Antwerp Belgium 6Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde Glasgow Scotland 7WHO Collaborating Centre for Research and Training in the Patient Perspective on Medicines Use, Department of Pharmacy, Faculty of Health and Medical Sciences University of Copenhagen Denmark 8Institute of Clinical Pharmacy, Faculty of Pharmacy, University of Szeged, Hungary 9Emergency Department, Albert Szent-Györgyi Medical Centre, Central Pharmacy, University of Szeged, Hungary10Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca Romania 11Pharmacoepidemiology Department, Andrija Štampar Teaching Institute of Public Health, Zagreb, Croatia12World Health Organization Geneva 13Pharmacy Services, NHS Greater Glasgow and Clyde Glasgow Scotland 14Pharmacology Unit, Department of Medical and Surgical Sciences University of Bologna Bologna Italy 15Discipline of Pharmacy, Graduate School of Health, University of Technology Sydney Sydney Australia 16WHO Collaborating Centre for Drug Statistics Methodology, Norwegian Institute of Public Health Oslo Norway 17Antibiotic Resistance and Infection Prevention Norwegian Institute of Public Health Oslo Norway 18Health Services Research and Pharmacoepidemiology Unit, Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO) Valencia Spain 19 AOK Research Institute (WIdO) Berlin Germany 20Department of PharmacoTherapy, Epidemiology & Economics, Faculty of Science and Engineering University of Groningen Groningen The Netherlands 21Department of Pharmacology and Toxicology, Faculty of Medicine Novi Sad University of Novi Sad Novi Sad Serbia 22WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department Austrian National Public Health Institute Vienna Austrua

KEY MESSAGES

Drug utilization research (DUR) can be defined as “Quantitative and qualitative studies to describe, evaluate, understand and improve the use of medicines”.

The discipline may be seen as the bridge between pharmacoepidemiology and health services research. The principal aim of DUR is to facilitate the safe and effective use of medicines in different populations and the society.

Research in drug utilization began to develop in the 1960s. Some pioneering studies focused on assessing differences in drug utilization between countries or regions. Other studies focused on factors influencing the prescribing patterns of physicians. These are still important areas of inquiry in DUR.

The eclectic nature of DUR requires expertise in a broad range of research methodologies. Part 2 of the book provides guidance on several quantitative and qualitative methods used in drug utilization research.

The numerous applications of DUR are illustrated in Part 3, which include sections on health policy, comparative drug utilization studies, drug utilization in specific populations and therapeutic areas, medication adherence, the role of drug utilization within other scientific fields, and the assessment and improvement of the quality of medicine use.

The nature of the scientific questions and the types of drug utilization studies vary across the world. This is illustrated in Part 4 of the book where researchers from all over the world describe the state of the art in DUR in their region.

The importance of drug utilization research

Medicines have a major impact on health and are essential for the provision of optimal care. The introduction of antibiotics in the 1940s drastically changed medicine. In addition to treatment of infectious diseases, these drugs also enabled many modern medical procedures. During the last decades of the 20th century, new medicines further decreased mortality, shortened hospitalization duration, and improved quality of life for millions of people [1]. The first decades of the 21st century have brought further advances in drug therapy with the introduction of many new biologicals and targeted treatments for cancer, orphan diseases, and other areas of high unmet medical need [2].